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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99NR017829-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using infographics. Data will be collected from participants through baseline (at enrollment) and follow up assessments at 3- and 6-month follow up visits). Follow up interviews will be conducted with members of the clinical team to ascertain their perspectives on the clinical utility of infographics.
Latinos are the largest and fastest growing minority group in the US, and they are disproportionately affected by HIV. In 2014, almost 25% of new cases of HIV infections were among Latinos although they only represent 17% of the US population. Additionally, Latinos have a faster rate of progression from HIV to AIDS, higher rates of HIV-related deaths, and marked delay in the diagnosis of infections. Approximately 42% of HIV diagnoses among Latinos in the US are in persons born abroad. In absolute numbers, new HIV diagnoses among foreign-born individuals in the US were the highest among Caribbean-born persons, which may partially be attributed to high rates of bidirectional travel. It is, therefore, critical that HIV prevention and treatment activities incorporate factors associated with Latino immigrant and transnational groups. In Washington Heights, New York City, understanding these factors related with bi-directional travel to the Dominican Republic (DR) is warranted, as the Latino population of Washington Heights is largely comprised of Dominicans.
Many factors contribute to the health disparities experienced by Latinos, of which low health literacy and literacy in general are potential contributors. Health literacy, or "the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions," is an established concern affecting vulnerable communities globally. Not surprisingly, Spanish-speaking, less educated, and/or foreign-born Latinos have lower health literacy than those born in the US. Low health literacy can lead to worse health outcomes, less use of services, and poorer knowledge of illness. Also, patients with limited health literacy are likely to have low numeracy which affects interpretations of medication quantities, time between doses, and time between appointments, among other quantitative knowledge relating to effective management of HIV.
Infographics are emerging technologies to help teach complex health concepts to patients with low health literacy. When effectively designed, infographics (information visualizations) contain a depth and breadth of information and lead to improved understanding of concepts. By carefully selecting the design and included content, simple images can convey large amounts of information in a visually appealing and comprehensible way. Methodically constructed infographics have been shown to improve communication about health behaviors and health risks and minimize comprehension differences between individuals with high and low health literacy. They can also help improve information exchange amidst culture and language differences by using images familiar to patients to explain complicated processes as well as augment attention span and recall of learned material. Furthermore, rigorously designed and evaluated infographics can help mitigate health disparities by helping clinicians provide the information that people need for effective health management in an understandable way.
During preliminary studies, the investigators developed a set of infographics designed to facilitate HIV-related clinician-patient communication during clinic visits. Initial infographics were designed by persons living with HIV (PLWH) in the Dominican Republic and are now being tested for feasibility and usability among a cohort in the DR. In this study, the investigators propose to assess the feasibility of using the infographic intervention in a clinic that specializes in HIV care in Washington Heights to improve clinical communication and subsequently, patient outcomes. Additionally, the investigators will collect information about acculturation and bi-directional travel to more thoroughly assess how these factors relate to HIV infection among Hispanic/Latino populations living in the US.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infographic intervention group | Experimental | Participants in the infographic intervention group will receive health education using infographics during a study visit scheduled immediately following their regularly scheduled clinic visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infographic intervention | Other | Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CD4 Count | Mean Cluster of Differentiation 4 (CD4) count at each time point. | Baseline, 3-, and 6-months |
| Mean Viral Load | Mean viral load at each time point | Baseline, 3-, and 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score on HIV-related Knowledge Assessment | 14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, MPH, RN | Columbia University | Principal Investigator |
| Samantha B Stonbraker, PhD, MPH, RN | Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive HIV Program of NewYork-Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Passel J, Cohn D, Lopez M. Hispanics account for more than half of nation's growth in past decade. Washington DC: Pew Hispanic Center;2011. | ||
| Background | Brown A, Hugo Lopez M. Mapping the Latino Population, By State, County and City. Washington DC2013. | ||
| 23184612 | Background | Henao-Martinez AF, Castillo-Mancilla JR. The Hispanic HIV Epidemic. Curr Infect Dis Rep. 2013 Feb;15(1):46-51. doi: 10.1007/s11908-012-0306-0. | |
| 18498050 |
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De-identified data of individual participant data will be made available to qualified researchers seeking to replicate methods or to those working on a new study who need the evidence-base to do so in a rigorous way. All de-identified participant data will be shared with other researchers. Please note that much of this data will be in Spanish.
Data will be available 3 months after the publication of primary results.
To request data please email the study director listed on this record with the reason you need the data and your planned use of it.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infographic Intervention Group | Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits. Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two participants were removed from the study by the PI. Their information was not included in the calculations of participants' characteristics at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits. Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean CD4 Count | Mean Cluster of Differentiation 4 (CD4) count at each time point. | 2 participants were withdrawn by the PI and were not included in analyses. | Posted | Mean | Standard Deviation | Cells/mm^3 | Baseline, 3-, and 6-months |
|
Each participant was assessed while they were enrolled in the study, for up to 9 months (at 6-month visit) from baseline.
We collected data for any adverse events that occurred during study-related activities.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits. Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits. |
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The global COVID-19 pandemic caused a research pause in mid-March 2020. This made it so that some of our participants were not able to complete their second out of three possible visits. Research activities were able to resume in May 2020 with strict COVID-19 safety measures in place. However, participants' third study visits were delayed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samantha Stonbraker | University of Colorado College of Nursing | 3037248281 | Samantha.Stonbraker@CUAnschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2019 | Aug 11, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2019 | Aug 13, 2021 | ICF_002.pdf |
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This study will use a single pretest-posttest design to evaluate if using infographics for patient education can lead to improved patient outcomes.
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| Baseline, 3-, and 6-months |
| Mean Score on Satisfaction With Care Scale | 7 questions on patients' satisfaction with health care provider and the health care center adapted from previously validated instruments were included. Each question response from included questions has a different score range: Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5 Question 5: 1 - 7 Question 6: 1 - 7 Question 7: 1 - 5 Total scores range from 7 - 48, which is calculated from the lowest and highest possible scores on each of the included questions. Higher scores indicating more satisfaction with care. | Baseline, 3-, and 6-months |
| Mean Score on the SEMCD Scale | The Self-Efficacy for Managing Chronic Disease (SEMCD) scale is a 6-item questionnaire that measures confidence in one's ability to manage fatigue, pain, emotional distress, and other symptoms using self-management techniques. Each item is scored from a minimum value of 1 which indicates "not at all confident" to a maximum score of 10, which indicates "completely confident." Final scores are calculated as the mean of the 6 questions ranging from 1(minimum) to 10 (maximum), where higher scores indicate higher self-efficacy (better outcome). | Baseline, 3-, and 6-months |
| Number of Participants Who Are Adherent to Their Medications | Adherence will be measured with the validated simplified medication adherence questionnaire (SMAQ)-6 scale, a 6-item questionnaire. A person is considered "non-adherent" if there is a "yes" answer for any of items 1,2,3, and 5. Additionally, if they answer that they have missed more than two doses of their medication in the past week (item 4) or if they have gone more than two days without taking their medication in the past 3 months (item 6), they are also considered "non-adherent." | Baseline, 3-, and 6-months |
| Number of Participants Who Reported Each of the 5 General Health Categories | Participants rated their general health as "excellent," "very good," "good," "more or less," or "bad." | Baseline, 3-, and 6-months |
| Mean Score on Current Health Status | Current health status will be assessed with one question from the Health Status Assessment which asks participants to rate their current health by providing a number on a scale from 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health. | Baseline, 3-, and 6-months |
| Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E Measurement | Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and a score above a 15 indicates that participants are likely to have adequate health literacy. | Baseline visit only |
| Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS Measurement | A second measure of health literacy, the Newest Vital Sign (NVS) will also be administered. Scores on this scale range from 0-6 where a score of 0-1 suggests high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy. | Baseline visit only |
| Number of Participants in Each Acculturation Category Presented in the Brief ARSMA | The Brief Acculturation Rating Scale for Mexican Americans-II (Brief ARSMA)12 item instrument that assesses level of acculturation that has been used in Mexican Americans as well as other Latino subgroups, including Dominicans. Scores are calculated by summing the scores and dividing by 12 to get a mean acculturation. Higher scores indicate greater acculturation. | Baseline visit only |
| Percent of Participants Who Complete an In-depth Qualitative Interview | Participants will be invited to participate in an in-depth qualitative interview regarding their experiences. The number who participate will be reported as a percent of the total who are enrolled. | 6 months after baseline |
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| 17931135 | Background | Osborn CY, Weiss BD, Davis TC, Skripkauskas S, Rodrigue C, Bass PF, Wolf MS. Measuring adult literacy in health care: performance of the newest vital sign. Am J Health Behav. 2007 Sep-Oct;31 Suppl 1:S36-46. doi: 10.5555/ajhb.2007.31.supp.S36. |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Country of birth | Count of Participants | Participants |
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| Married or in a serious relationship | Count of Participants | Participants |
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| Highest level of education completed | Count of Participants | Participants |
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| New Patient | Count of Participants | Participants |
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| Years living with HIV | Mean | Standard Deviation | Years |
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| Years attending the clinic | Mean | Standard Deviation | Years |
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| Preferred language of participation | Count of Participants | Participants |
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| Primary | Mean Viral Load | Mean viral load at each time point | 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis. | Posted | Mean | Standard Deviation | copies/mL | Baseline, 3-, and 6-months |
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| Secondary | Mean Score on HIV-related Knowledge Assessment | 14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge. | 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-, and 6-months |
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| Secondary | Mean Score on Satisfaction With Care Scale | 7 questions on patients' satisfaction with health care provider and the health care center adapted from previously validated instruments were included. Each question response from included questions has a different score range: Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5 Question 5: 1 - 7 Question 6: 1 - 7 Question 7: 1 - 5 Total scores range from 7 - 48, which is calculated from the lowest and highest possible scores on each of the included questions. Higher scores indicating more satisfaction with care. | 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-, and 6-months |
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| Secondary | Mean Score on the SEMCD Scale | The Self-Efficacy for Managing Chronic Disease (SEMCD) scale is a 6-item questionnaire that measures confidence in one's ability to manage fatigue, pain, emotional distress, and other symptoms using self-management techniques. Each item is scored from a minimum value of 1 which indicates "not at all confident" to a maximum score of 10, which indicates "completely confident." Final scores are calculated as the mean of the 6 questions ranging from 1(minimum) to 10 (maximum), where higher scores indicate higher self-efficacy (better outcome). | 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-, and 6-months |
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| Secondary | Number of Participants Who Are Adherent to Their Medications | Adherence will be measured with the validated simplified medication adherence questionnaire (SMAQ)-6 scale, a 6-item questionnaire. A person is considered "non-adherent" if there is a "yes" answer for any of items 1,2,3, and 5. Additionally, if they answer that they have missed more than two doses of their medication in the past week (item 4) or if they have gone more than two days without taking their medication in the past 3 months (item 6), they are also considered "non-adherent." | 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis. | Posted | Count of Participants | Participants | Baseline, 3-, and 6-months |
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| Secondary | Number of Participants Who Reported Each of the 5 General Health Categories | Participants rated their general health as "excellent," "very good," "good," "more or less," or "bad." | 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis. | Posted | Count of Participants | Participants | Baseline, 3-, and 6-months |
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| Secondary | Mean Score on Current Health Status | Current health status will be assessed with one question from the Health Status Assessment which asks participants to rate their current health by providing a number on a scale from 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health. | 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-, and 6-months |
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| Secondary | Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E Measurement | Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and a score above a 15 indicates that participants are likely to have adequate health literacy. | 2 participants were withdrawn from the study by the PI and, therefore, their data are not included in the analysis. | Posted | Count of Participants | Participants | Baseline visit only |
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| Secondary | Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS Measurement | A second measure of health literacy, the Newest Vital Sign (NVS) will also be administered. Scores on this scale range from 0-6 where a score of 0-1 suggests high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy. | 2 participants were withdrawn from the study by the PI and, therefore, their data are not included in analyses. | Posted | Count of Participants | Participants | Baseline visit only |
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| Secondary | Number of Participants in Each Acculturation Category Presented in the Brief ARSMA | The Brief Acculturation Rating Scale for Mexican Americans-II (Brief ARSMA)12 item instrument that assesses level of acculturation that has been used in Mexican Americans as well as other Latino subgroups, including Dominicans. Scores are calculated by summing the scores and dividing by 12 to get a mean acculturation. Higher scores indicate greater acculturation. | 2 participants were withdrawn from the study by the PI and, therefore, were not included in analyses | Posted | Count of Participants | Participants | Baseline visit only |
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| Secondary | Percent of Participants Who Complete an In-depth Qualitative Interview | Participants will be invited to participate in an in-depth qualitative interview regarding their experiences. The number who participate will be reported as a percent of the total who are enrolled. | 2 participants were withdrawn from the study by the PI and, therefore, they are not included in analyses. | Posted | Count of Participants | Participants | 6 months after baseline |
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| 30 |
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| 30 |
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| 30 |
Not provided
Not provided
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| Exposure 3 |
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| Statistical analysis of viral load between baseline/exposure 1 and exposure 3 to the intervention. | Quantile Regression | 0.5971 | The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05. | Median Difference (Net) | -63.00 | 2-Sided | 95 | -296.1 | 170.1 | Other | In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 3 to the intervention. | This is the difference in median viral load between baseline/exposure 1 and exposure 3. |
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| Exposure 3 |
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In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 2 to the intervention. |
| Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 3 to the intervention. | Quantile Regression | Random intercepts for subjects were included in the model. | <.0001 | The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05. | Median Difference (Net) | 2.00 | 2-Sided | 95 | 1.2 | 2.8 | This is the difference in median HIV-related knowledge score between baseline/exposure 1 and exposure 3. | Other | In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 3 to the intervention. |
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| Exposure 3 |
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| Exposure 3 |
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In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 2 to the intervention. |
| Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention. | Quantile Regression | Random intercepts for subjects were included in the model. | 0.1550 | The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05. | Median Difference (Net) | 0.57 | 2-Sided | 95 | -0.2 | 1.4 | This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 3. | Other | In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 3 to the intervention. |
| Exposure 2 |
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| Exposure 3 |
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In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 2 giving an odds ratio of one for the null hypothesis. |
| For analysis, we dichotomized participants adherence as "adherent" or "non-adherent." | Regression, Logistic | This model included random effects for subjects. | 0.1332 | The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05. | Odds Ratio (OR) | 0.3 | 2-Sided | 95 | 0.07 | 1.43 | In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 3 relative to the odds of being non-adherent at baseline/exposure 1. | Other | In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 3 giving an odds ratio of one for the null hypothesis. |
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| Excellent |
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| Missing |
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| Exposure 2 |
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| Exposure 3 |
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| Other |
In this model, the null hypothesis was that the odds of good health at baseline/exposure 1 were exactly equal to the odds of good health at exposure 2 giving an odds ratio of one for the null hypothesis. |
| For analysis, we dichotomized participants' responses into the following categories: "good" vs "bad" health, where "good" included participant responses: "excellent," "very good," "good," and "bad" included the participant responses: "more or less" and "bad." | Regression, Logistic | This model included random effects for subjects. | 0.8609 | The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05. | Odds Ratio (OR) | 1.12 | 2-Sided | 95 | 0.32 | 3.93 | This is the estimated odds ratio of having good health at exposure 3 relative to baseline/exposure 1. | Other | In this model, the null hypothesis was that the odds of having good health at baseline/exposure 1 were exactly equal to the odds of having good health at exposure 3 giving an odds ratio of one for the null hypothesis. |
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| Exposure 3 |
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In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 2 to the intervention. |
| Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention. | Quantile Regression | Random intercepts for subjects were included in the model. | 0.0332 | The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05. | Median Difference (Net) | 13.10 | 2-Sided | 95 | 1.1 | 25.1 | This is the difference in median current health status between baseline/exposure 1 and exposure 3. | Other | In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 3 to the intervention. |
| Strongly Anglo oriented |
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| Very assimilated |
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